GaitNCT06665685
BioButton Among Nursing Home Residents
A study testing BioButton Device and Providing Clinical Care with BioButton Device in people with Gait and Medication Induced Gait Disturbances, run by Charles Lin at 1 site in United States.
Trial summary
This pilot study will explore the use of the BioIntellisense BioButton, a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gait, Medication Induced Gait Disturbances
- What is being tested?
- BioButton Device and Providing Clinical Care with BioButton Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2025to 18 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18yrs
- Presence of gait documentation in EMR
Who cannot join
- Age <18yrs
- Non-English-speaking patients
- Patients who cannot provide consent due to cognitive status
- Bedbound, unable to stand
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Canterbury Place
Pittsburgh, Pennsylvania, 15201
About this study
Official title: Using Gait Data to Inform Prescription Practice Among Nursing Home Residents to Reduce Medication-Induced Gait Disturbances
This pilot study will explore the use of the BioIntellisense BioButton, a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy.
Read the detailed description
By 2030, an anticipated seven adults over 65 years old are projected to die every hour from a fall in the United States. This highlights the growing percentage of the elderly in our population and the impact of falls on them. Nationally, over 25% of older adults report falling each year and falls are the leading cause of fatal and non-fatal injuries. In Pennsylvania, 30% of older adults report falling each year, an underreported value that can be as high as 60%. The cost of care for falls is over $50 billion annually in the United States according to the Centers for Disease Control (CDC). Nursing home residents are especially at risk; among nursing home residents, the risk of falling is 2x greater than community residents.
Nursing home residents who take multiple medications especially antidepressants, anxiolytics, and blood pressure drugs have an increased risk for falling. Polypharmacy especially the use of five or more medications is significantly associated with a 21% increase of falls. Unfortunately, gait data is not routinely collected or available to geriatric clinicians for making medication decisions. Empowering clinicians with gait data can be a powerful piece of the puzzle; this information may help them decide whether the benefit of starting a new anti-hypertensive or mood medication is worth the risk.
Clinicians informed with gait data can make better medication decisions for their elderly patients; they will be able to consider gait disturbance and fall risk in their clinical judgement. As a result, gait data from continuous wearable technology can adjust medication practices, and reduce medication-induced falls. Moreover, the concept for gait-informed prescription practice complements the 4Ms (what matters, medication, mentation, and mobility) employed by age-friendly health systems. Continuous gait data can inform the implementation of the 4Ms by (1) engaging patients and their families about their care priorities related medications and their impact on gait, (2) adjusting medications that affect mobility, and (3) addressing depression treatment with behavioral modifications instead of medications. Results from this project can inform future studies that will move the needle towards implementing care practices consistent with the 4Ms.
- Conditions
- Gait, Medication Induced Gait Disturbances
- Being tested
- BioButton Device, Providing Clinical Care with BioButton Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioButton DeviceDevice
BioButton is a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy. This arm will be the patient wearing the device during their Nursing Home stay for 30-days.
Providing Clinical Care with BioButton DeviceDevice
BioButton is a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy. This arm will provide care for patients wearing the BioButton device during their Nursing Home stay for 30-days.
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Experimental | Patients in this arm will wear the device, BioButton, continuous for 30 days as it collects physiologic and gait data, while receiving otherwise routine, standard of care. Receives: Device: BioButton Device |
| Nurse Group | Experimental | Nurses caring for patients wearing the device, BioButton, will assist in placing and removing the device. Otherwise, they will provide routine, standard of care to the enrolled patients to determine the overall feasibility of the device for clinical care providers. Receives: Device: Providing Clinical Care with BioButton Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Device-Related Adverse Events
Number of participants experiencing device-related adverse events during the 30-day monitoring period, including clinically significant skin injury or discomfort attributable to wearing the BioButton.
Measured: 30-days
Number of Participants Who Completed the 30-Day Monitoring Period
Number of enrolled participants who completed the full 30-day BioButton monitoring period.
Measured: 30-days
Participant Acceptability of the BioButton at 7-days
Participant acceptability and tolerability of the BioButton were assessed using an 11-item survey administered after 7-days of wear. Survey items evaluated ease of placement, comfort, interference with activities and sleep, skin irritation, device stability, and perceived monitoring. Results are reported as the number and percentage of participants answering "Yes" to each item.
Measured: 7-days
Participant Acceptability of the BioButton at 30-days
Participant acceptability and tolerability of the BioButton were assessed using an 11-item survey administered after 30-days of wear. Survey items evaluated ease of placement, comfort, interference with activities and sleep, skin irritation, device stability, and perceived monitoring. Results are reported as the number and percentage of participants answering "Yes" to each item.
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start11 Mar 2025
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Study design will enroll arm 1 of 60 patients who will wear the device, BioButton, during their nursing home care. Arm 2 will consist of 10 nurses who have been assigned to care for one or more of the patients in Arm 1 to discuss device feasibility in terms of clinical care.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Lin
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish Healthcare Foundation
- Responsible party
- Sponsor-investigator, Charles Lin, University of Pittsburgh
- Investigators
- Charles Lin, MD, Principal investigator, UPMC, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665685
- Sponsor's protocol ID
- STUDY24050088
- Status last verified
- Dec 2025
- First submitted
- 29 Oct 2024
- Last updated
- 14 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Gait Data to Inform Prescription Practice Among Nursing Home Residents to Reduce Medication-Induced Gait Disturbances
- ClinicalTrials.gov ID
- NCT06665685
- Acronym / sponsor ID
- STUDY24050088
- Conditions
- Gait, Medication Induced Gait Disturbances
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Charles LinUniversity, hospital or other
- Collaborators
- Jewish Healthcare Foundation
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Posted 14 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will explore the use of the BioIntellisense BioButton, a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy.
Detailed description
By 2030, an anticipated seven adults over 65 years old are projected to die every hour from a fall in the United States. This highlights the growing percentage of the elderly in our population and the impact of falls on them. Nationally, over 25% of older adults report falling each year and falls are the leading cause of fatal and non-fatal injuries. In Pennsylvania, 30% of older adults report falling each year, an underreported value that can be as high as 60%. The cost of care for falls is over $50 billion annually in the United States according to the Centers for Disease Control (CDC). Nursing home residents are especially at risk; among nursing home residents, the risk of falling is 2x greater than community residents.
Nursing home residents who take multiple medications especially antidepressants, anxiolytics, and blood pressure drugs have an increased risk for falling. Polypharmacy especially the use of five or more medications is significantly associated with a 21% increase of falls. Unfortunately, gait data is not routinely collected or available to geriatric clinicians for making medication decisions. Empowering clinicians with gait data can be a powerful piece of the puzzle; this information may help them decide whether the benefit of starting a new anti-hypertensive or mood medication is worth the risk.
Clinicians informed with gait data can make better medication decisions for their elderly patients; they will be able to consider gait disturbance and fall risk in their clinical judgement. As a result, gait data from continuous wearable technology can adjust medication practices, and reduce medication-induced falls. Moreover, the concept for gait-informed prescription practice complements the 4Ms (what matters, medication, mentation, and mobility) employed by age-friendly health systems. Continuous gait data can inform the implementation of the 4Ms by (1) engaging patients and their families about their care priorities related medications and their impact on gait, (2) adjusting medications that affect mobility, and (3) addressing depression treatment with behavioral modifications instead of medications. Results from this project can inform future studies that will move the needle towards implementing care practices consistent with the 4Ms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study design will enroll arm 1 of 60 patients who will wear the device, BioButton, during their nursing home care. Arm 2 will consist of 10 nurses who have been assigned to care for one or more of the patients in Arm 1 to discuss device feasibility in terms of clinical care.
| Arm | Type | Receives |
|---|---|---|
| Patient Group | Experimental | Device: BioButton DevicePatients in this arm will wear the device, BioButton, continuous for 30 days as it collects physiologic and gait data, while receiving otherwise routine, standard of care. |
| Nurse Group | Experimental | Device: Providing Clinical Care with BioButton DeviceNurses caring for patients wearing the device, BioButton, will assist in placing and removing the device. Otherwise, they will provide routine, standard of care to the enrolled patients to determine the overall feasibility of the device for clinical care providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18yrs
- Presence of gait documentation in EMR
Key exclusion criteria (4 listed)
- Age <18yrs
- Non-English-speaking patients
- Patients who cannot provide consent due to cognitive status
- Bedbound, unable to stand
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioButton DeviceBioButton is a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy. This arm will be the patient wearing the device during their Nursing Home stay for 30-days. | Device | Patient Group |
| Providing Clinical Care with BioButton DeviceBioButton is a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy. This arm will provide care for patients wearing the BioButton device during their Nursing Home stay for 30-days. | Device | Nurse Group |
Primary outcome
Number of Participants With Device-Related Adverse Events
Time frame: 30-days
Number of participants experiencing device-related adverse events during the 30-day monitoring period, including clinically significant skin injury or discomfort attributable to wearing the BioButton.
Number of Participants Who Completed the 30-Day Monitoring Period
Time frame: 30-days
Number of enrolled participants who completed the full 30-day BioButton monitoring period.
Participant Acceptability of the BioButton at 7-days
Time frame: 7-days
Participant acceptability and tolerability of the BioButton were assessed using an 11-item survey administered after 7-days of wear. Survey items evaluated ease of placement, comfort, interference with activities and sleep, skin irritation, device stability, and perceived monitoring. Results are reported as the number and percentage of participants answering "Yes" to each item.
Participant Acceptability of the BioButton at 30-days
Time frame: 30-days
Participant acceptability and tolerability of the BioButton were assessed using an 11-item survey administered after 30-days of wear. Survey items evaluated ease of placement, comfort, interference with activities and sleep, skin irritation, device stability, and perceived monitoring. Results are reported as the number and percentage of participants answering "Yes" to each item.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Lin, MD principal investigator
UPMC, University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioButton Device and Providing Clinical Care with BioButton Device in people with Gait and Medication Induced Gait Disturbances, run by Charles Lin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Device-Related Adverse Events (time frame: 30-days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 3 Nov 2026.